European medical device regulatory law and product liability

The regulatory system for medical devices is quite different from that for pharmaceuticals and may catch many people unawares. For instance, it does n ot involve the grant of a marketing authorization by a medicines agency. In stead, a 'declaration of conformity' is made by the manufacturer, but in ma ny instances this is subject to approval by an independent certification ho use (known as a notified body). The Medical Devices Directive 93/42/EEC is applied in each EEA State by nat ional Legislation. In the UK, for example, the relevant law is the Medical Devices Regulations 1994, and responsibility for enforcement rests with the Medical Devices Agency. Non-compliance with the regulations can incur a cr iminal penalty. (C) 1999 The Hospital Infection Society.